LEAD QUALITY ENGINEER

Title: Lead Quality Engineer
Location: Sunnyvale, CA
Duration: 3+ MONTHS

Role Summary/Purpose
This position is responsible for providing engineering and/or manufacturing process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service.
Essential Responsibilities
1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2. Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
3. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
4. Responsible for supporting product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
5. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
6. Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans.
7. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
8. Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
9. Ensures process compliance through use of procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
10. Performs a broad variety of tasks in support of product and process design as assigned by manager.